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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrocardiograph, ambulatory, with analysis algorithm
Regulation Description Medical magnetic tape recorder.
Product CodeMLO
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
AGILENT TECHNIOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
DIAGNOSTIC MONITORING SOFTWARE
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
INOVISE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDICK HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICOMP
  SUBSTANTIALLY EQUIVALENT 1
MORTARA
  SUBSTANTIALLY EQUIVALENT 1
NORAV MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1

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